MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012454-20
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Medwatch report#: mw (b)(4).
Event or Problem Description
User facility medwatch report received that states "describe the event or problem: a non-compliant balloon was used to post dilate the rca coronary/ stent.The balloon was inflated to 14 atm.For 24 sec.At conclusion unable to deflate the balloon.Numerous attempts were made to deflate the balloon.The balloon was able to be removed from the rca to the aorta.The balloon was successfully ruptured with over-inflation of the balloon.The balloon was successfully removed.What was the original intended procedure ? patient underwent a coronary artery intervention to the right coronary artery.What problem did the user have (check all that apply): device malfunction - that is, the device did not do what it was supposed to do; ".No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to deflate appears to be related to use error; however, the reported entrapment of device or device component and unexpected medical intervention appear to be related to circumstances of the procedure.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu), specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, it is likely that the concentrated contrast solution contributed to the reported failure to deflate.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: device code 2017: improper or incorrect procedure or method.
Event or Problem Description
Subsequently, after the initial report was filed it was noted the contrast ratio was 2:1 contrast to saline.Another device was used to successfully complete the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16640026
• Report Number: 2024168-2023-03185
• Device Sequence Number: 6120696
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 20701G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 86 KG